Symogen, a UK-based company with expertise in all aspects of pharmacovigilance and pharmacoepidemiology, will start a highly intensive and focused course on pharmacovigilance and pharmacoepidemiology from September 2007.
Talking to Pharmabiz, Dr Pipasha Biswas, pharmaceutical medicine physician and consultant of Symogen, said, "This new course will not only help to give exposure to candidates with genuine interest in the area to develop themselves and gain knowledge, but will also produce talented individuals who will be ready to work for pharmaceutical companies and regulatory agencies in this area".
It will be a four-month intensive course meant for physicians. It is intended for both graduate level and post-graduate level, for post graduate pharmacists and PhD scientists. Admission to this course will be strictly on merit and with those having genuine interest in this area. In this course, there will have bi-annual intake, September to December and January to April. It will be held in two locations in the country. While the September to December course will be held in New Delhi, the January to April course will be held in Mumbai.
Symogen already has a state of the art pharmacovigilance and pharmacoepidemiology set-up based in New Delhi, with MedDRA Dictionary support, SAS and Oracle Clinical based platform for adverse event reporting software for undertaking various pharmacovigilance activities including signal detection.
Apart from this, Symogen has the experience in development of EU pharmacovigilance risk management plans for submission to the EMEA and FDA as part of phase III approval process and also for ongoing pharmacovigilance activities. Symogen also supports and helps in the writing and production of periodic safety update reports (PSURs) and annual safety reports (ASRs) for clinical trials and reporting and submission of ADR reports to various regulatory authorities via E2B.
The company has experienced and knowledgeable personnel in EEA, FDA and TGA regulations who have the experience in working in reputed MNCs in UK and USA. It intends to work closely with the DCGI office and has good working relations with various other European and American regulatory authorities. Hence, companies can take the help of Symogen, if they conduct any pharmacovigilance activities, within India or in EEA countries or USA for any drug approval process and subsequent launch of their products in those countries as per the required regulations.